* Background
Pharmaceutical regulations are ?the combination of legal, administrative, and technical measures that governments take to ensure the safety, efficacy, and quality of medicines, as well as the relevance and accuracy of product information [1]. The choice of pharmaceutical regulations in a country determines its National Medicines Regulatory Systems (NMRS). Therefore, pharmaceutical regulation is key to achieving universal health coverage (UHC) because medicines are the cornerstone in utilization of health services. This is significant in developing countries, especially in Sub-Saharan Africa, where according to the World Health Organization (WHO), health indicators are comparatively poor.
My earlier research on out-of-pocket health expenditure and how these payments limit access to health avers that UHC is a key agenda in Kenya, as well as many other developing countries by extension [2]. Furthermore, medicines ? considered as part of health, products and technologies ? compose one of WHO?s frameworks of a health system, hence underscoring their role. The WHO estimates that about 2 billion people worldwide lack access to medicines. While this challenge requires multifaced solutions, there is no doubt that any steps that strengthens NMRS would be a step in the right direction towards access to healthcare.
* Problem statement
Developing countries have limited economic resources, high disease burden, low pharmaceutical manufacturing capacity and a diverse pharmaceutical supply chain [3]. Therefore, their ability to select regulatory policies that optimize vital qualities of health products, especially medicines, is key to strengthening NMRS. This rests on the decision-making models and tools adopted by the medicine regulatory authorities. It is this process, through which these countries select one regulatory policy over the other that this study would seek to tremendously improve.
Unlike the developed countries, developing countries scarcely use evidence-based tools in developing health policy and regulation [4,5].The awakening in the need to apply these tools stem from the realization that decision analysis during policy formulation for national medicines regulatory systems results into better pharmaceutical regulation. This research?s main objective is to study application of Multi-Criteria Decision Analysis (MCDA) to select the most suitable medicines regulatory policies.
In Kenya, the medicines regulatory authority, known as Pharmacy and Poisons Board (PPB), is responsible for the decision analysis of different policy options for pharmaceutical regulation. However, MCDA is not applied as such policies are lifted, as templates, from developed countries and tailored for local use. A search in the major common databases, for instance google scholar, PubMed and Scopus reveals no related studies for Kenya. UHC is one of the four key agenda that Kenya intends to achieve, with emphasis on pharmaceuticals and basic medical supplies as an anchor [6]. This study, therefore, will strengthen this anchor and enhance the pathway towards UHC for Kenya.
* Niche and research interests
In Kenya, skilled professionals with dual technical expertise in both pharmacy and health economics lack, I would be a great addition if I were to successfully complete this research. Furthermore, my research interests in health care financing, health equity and inequality, economic evaluation in health care and health technology assessment uniquely suit me to successfully undertake this study.
* Methodology
This is a qualitative study that will seek to research MCDA in choice of different medicines? regulatory policies in Kenya, leading to selection of the most effective and efficient pharmaceutical regulation. Data will be collected through interviews with key informants, who will be sampled from the stakeholders involved in NMRS in Kenya. A questionnaire may be used to collect other data. I have attached a schedule of how I intend to accomplish the study withi

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